Trial document





This trial has been registered retrospectively.
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  DRKS00012759

Trial Description

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Title

Investigating the German response scale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) – a three-step approach

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Trial Acronym

EORTC Response Scale

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URL of the Trial

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Brief Summary in Lay Language

The original EORTC questionnaire assess the quality of life of patients with cancer. The questionnaie was developed in English, and other language versions, including German, were created in parallel. With exception of two items, all items of the actual Version are scored on a 4-point Likert scale: 1 “not at all”, 2 “a little”, 3 “quite a bit”, and 4 “very much”. The German equivalents have been translated as 1 “überhaupt nicht”, 2 “wenig”, 3 “mäßig”, and 4 “sehr”.

The German term "mäßig" is close to the term "wenig", thus violating the interval properties of the scale. The present project will investigate whether the "mäßig" should be replaced by another term and whether this improves the measurement properties of the scale.

Patients participating in this study will fill in the questionnaire twice, once in the conventional design ("mäßig") and once in the updated design with the response alternative "ziemlich". The order of the questionnaire designs and the presentation modes (paper/pencil versus computer) will be randomized.

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Brief Summary in Scientific Language

The original EORTC questionnaire was formulated in English, and other language versions, including German, were created in parallel. With exception of two items, all items of the actual Version are scored on a 4-point Likert scale: 1 “not at all”, 2 “a little”, 3 “quite a bit”, and 4 “very much”. The German equivalents have been translated as 1 “überhaupt nicht”, 2 “wenig”, 3 “mäßig”, and 4 “sehr”.

The German term "mäßig" is close to the term "wenig", thus violating the interval properties of the scale. The present project will investigate whether the "mäßig" should be replaced by another term and whether this improves the measurement properties of the scale.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00012759
  •   2017/08/04
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  •   yes
  •   Approved
  •   14-101-0209, Ethikkommission an der Universität Regensburg
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Secondary IDs

  •   Z-2014-0368-2  (Zentrum für Klinische Studien Regensburg)
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Health Condition or Problem studied

  •   Adaption of the German version of the questionnaire for cancer patients EORTC QLQ-C30
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Interventions/Observational Groups

  •   Step I investigates the properties of the critical response term “mäßig” and its alternatives.
  •   Step II refers to the development of an updated German EORTC QLQ-C30 version with an improved response scale.
  •   Step III: Both questionnaires, conventional and updated, are available in a paper/pencil and a table version. Each patient fills in 2 qestionnaires and their assignment is randomized.

    Arm 3: conventional questionnaire/paper version
  •   Step III: updated questionnaire/paper version
  •   Step III: conventional questionnaire/tablet version
  •   Step III: updated questionnaire/tablet version
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

The primary endpoint is the score of the EORTC QLQ-C30 as calculated according to the scoring manual. The score will be calculated twice, with regard to the the first and the second assessment. The critical value of interest is the difference between scores of the conventional and the updated version. This difference will be assessed in the between (group comparisons) and within (before-after effects) conditions.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
  •   Switzerland
  •   Austria
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2016/04/01
  •   500
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Cancer, informed consent, ability to fill in a questionnaire

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Exclusion Criteria

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Addresses

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    • Universitätsklinikum RegensburgZentrum für Klinische Studien
    • Mr.  Prof. Dr.  Michael  Koller 
    • Franz-Josef-Strauss-Allee 11
    • 9053  Regensburg
    • Germany
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    • Universitätsklinikum RegensburgZentrum für Klinische Studien
    • Mr.  Prof. Dr.  Michael  Koller 
    • Franz-Josef-Strauss-Allee 11
    • 9053  Regensburg
    • Germany
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    • Universitätsklinikum RegensburgZentrum für Klinische Studien
    • Mr.  Prof. Dr.  Michael  Koller 
    • Franz-Josef-Strauss-Allee 11
    • 9053  Regensburg
    • Germany
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Sources of Monetary or Material Support

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    • European Organisation for Research and Treatment of Cancer
    • Av. E. Mounierlaan 83
    • 1200  Brüssel
    • Belgium
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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